Research in Context

Research in Context is a structured summary that editors at The Lancet’s journals ask all authors to provide when submitting an original research article. Read more

A collaboration with

Belzutifan PRO analyses in previously treated renal cell carcinoma

Exploratory secondary analyses from LITESPARK-005 suggested maintenance or improvement in PRO scores with belzutifan versus everolimus.

  • Thomas Powles, MD; Toni K Choueiri, MD; Laurence Albiges, MD; Katriina Peltola, MD PhD; Guillermo de Velasco, MD PhD; Mauricio Burotto, MD; et al.

  • March 17, 2025

  • The Lancet Oncology
  • The Lancet Oncology, Volume 26, Issue 4, Pages 491–502
  • 10.1016/S1470-2045(25)00032-4

Share

Evidence before this study

We searched PubMed for “renal cell carcinoma,” “RCC,” and “patient reported outcomes” on Feb 16, 2024, and found 12 relevant clinical trials published from 2008 to 2023. Six studies reported first-line treatment with immunotherapy alone or in combination with other agents (ie, nivolumab, nivolumab–ipilimumab, pembrolizumab–axitinib, lenvatinib–pembrolizumab, and atezolizumab–bevacizumab) versus sunitinib. Three studies reported patient-reported outcomes (PROs) from the tyrosine kinase inhibitors axitinib, lenvatinib, and sorafenib. Three studies reported PROs with everolimus as the comparator drug. In the phase 3 CheckMate 024 trial, nivolumab was associated with improvement in health-related quality of life compared with everolimus in previously treated participants with advanced renal cell carcinoma. In the phase 3 METEOR trial, cabozantinib maintained a quality of life similar to that shown with everolimus, but time to deterioration was improved with cabozantinib compared with everolimus. In the phase 3 RECORD-1 trial comparing everolimus and placebo in participants with metastatic renal cell carcinoma whose disease progressed on a vascular endothelial growth factor receptor tyrosine kinase inhibitor, no evidence of a difference between everolimus and placebo in longitudinal patterns of disease‑related symptoms was observed.

Added value of this study

The current study provides a summary of PRO measure analyses for the LITESPARK-005 phase 3 clinical trial, wherein participants were treated with belzutifan or everolimus. Efficacy results from LITESPARK-005 indicated that participants with previously treated renal cell carcinoma who received belzutifan showed more clinical benefit than those treated with everolimus. In the current study, PROs assessed via the Functional Assessment of Cancer Therapy-Kidney Cancer Symptom Index: Disease Related Symptoms and the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 as secondary outcomes further support the use of belzutifan rather than everolimus in this setting. Findings suggest that patients who received belzutifan had maintenance or improvement in PRO scores compared with those who received everolimus. Taken together, these results describe a positive risk–benefit profile for belzutifan.

Implications of all the available evidence

These results suggest that treatment with belzutifan for patients with advanced renal cell carcinoma could be associated with maintenance or improvement of health-related quality of life. The results are exploratory, and further research is required to support these PRO findings.

Source: The Lancet Oncology

Your research deserves a global audience

The Lancet Group reaches millions of clinicians and researchers worldwide.

Publish with The Lancet Group

Related Content

SBRT compared with other ablative therapies for localised renal cell carcinoma.

According to the authors, randomised trials are still needed to confirm long-term outcomes; a new large-scale meta-analysis suggests SBRT might be advantageous for larger tumours, with comparatively low rates of severe complications.

  • by Ryan S Huang, MSc; Ronald Chow, MS; Ali Benour, BSc; David Chen, BMSc; Gabriel Boldt, MLIS; Christopher J D Wallis, MD; et al.

  • February 5, 2025

Surgeon performing a minimally invasive procedure.
Phase 3 trial of investigational PET–CT imaging in cT1 indeterminate renal masses.

Researchers report high diagnostic performance for the investigational agent Zr-89-girentuximab PET–CT in identifying clear-cell renal cell carcinoma, with further trials warranted to assess patient-management effects and clinical utility in other renal cancer subtypes.

  • by Brian Shuch, MD; Allan J Pantuck, MD; Jean-Christophe Bernhard, MD; Michael A Morris, MD; Viraj Master, MD; Andrew M Scott, MD; et al.

  • September 10, 2024

PET/CT image showing areas of tracer uptake.